CEN/CLC/TC 3
| Projekta Nr. | CEN ISO/TS 24971-2:2026 |
|---|---|
| Nosaukums | This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2]. This document does not apply to MLMD employing large language models (LLM) or generative AI. |
| Reģistrācijas numurs (WIID) | 80075 |
| Darbības sfēra | This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2]. This document does not apply to MLMD employing large language models (LLM) or generative AI. |
| Statuss | Standarts spēkā |
| ICS grupa | 11.040.01 35.240.01 35.240.80 |